GMP & ISO Flashcards
What is the International Organization for Standardization (ISO)?
an international standard-setting body composed of representatives from various national standards organizations.
When was the ISO founded?
23 February 1947.
What does the ISO promote?
Worldwide proprietary, industrial, and commercial standards.
What are the key aspects of ISO participation?
- Consensus
- Timely
- Transparent
- Traceable.
What is the ISO process approach?
involves identifying and managing numerous linked activities,
* using resources,
* managing to enable the transformation of inputs into outputs,
* leadership commitment to customer requirements.
What is ISO 9000?
Family of quality management standards that includes 14 standards, with ISO 9001:2015 being the only one that can be certified to.
It provides an overview of how to put a QMS in place so that your organization can produce quality products and services.
What are the characteristics of ISO 9000?
processes are identified, analyzed, and managed; customer satisfaction is measured;
data are collected, analyzed, and used;
system effectiveness is continually improved.
What are the top 10 ISO standards?
The top 10 ISO standards are:
1. ISO 14001 (environmental),
2. ISO 27000 (information technology),
3. ISO 22000 (food safety),
4. ISO 50001 (energy),
5. ISO/TS 16949 (automotive industry),
6. ISO 13485 (medical equipment),
7. ISO 26000 (social responsibility),
8. ISO 31000 (risk management).
Where does the USP fit into ISO and GMPs?
The USP (United States Pharmacopeia) is a non-governmental organization that provides standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements. It fits into the GMPs, particularly for the pharmaceutical industry.
What is ISO 9001 and what is its focus?
ISO 9001 is a process-focused quality management system that requires processes to be measured, monitored, controlled, and improved.
Its focus is on continuous improvement and customer satisfaction.
